FDA characterizes today’s Safety Announcement requiring label changes for drugs that treat “low testosterone” merely “an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.” But it is obviously much more.

According to today’s announcement,

  1. FDA is “requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.”
  2. “[FDA is] also requiring manufacturers [ of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”
This is worlds apart from what the FDA said on January 31, 2014 regarding this issue. It is also worlds apart from what Public Citizen petitioned the FDA to do in February, 2014.

The January 2014 announcement (“Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events”) stated:

“FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.”

Another major difference this time is FDA’s acknowledgement that it FDA has “become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.” And FDA urges Health care professionals to prescribe testosterone therapy “only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.”

Only about one-half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy (see here).

As I reported back in February 2014, Public Citizen urged the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. (see “Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling“).

After that petition, FDA admitted in September, 2014, that “Men Who Receive Drugs for ‘Low-T’ Have 30% Increased Risk of Major Adverse Cardiovascular Events” and called for an advisory hearing. That advisory committee overwhelmingly recommended a tightening of label indications for “Low-T” drugs and renewed efforts to curb off-label use.

In November, 2014, Medical Mutual of Ohio sued Abbvie, Abbott Laboratories, Solvay America, Eli Lilly and Company, Auxilium Pharmaceutical, and Actavis Pharma, complaining that aggressive disease-awareness campaigns led millions of men to think that their lack of energy was a “low-T,” problem. “These TRT [testosterone-replacement therapy] drugs were marketed as part of a decade-long deceptive marketing scheme to transform the male aging process into a curable disease state defendants variously called ‘Andropause,’ ‘late-onset male hypogonadism,’ ‘age-related hypogonadism,’ or simply ‘Low T, which were invented from whole cloth,” the 341-page complaint states.

Against this headwind, FDA had no choice but to “update” it’s testosterone Safety Announcement.